Understanding Post-Approval Changes

Overview

A UL EduNeering course

This course covers the definition and purpose of post-approval changes (PAC). It explores the four categories of change—components and composition, scale of manufacture, site of manufacture, and manufacturing—and the requirements for each level of change. Participants will learn about PAC guidance and how these documents are used to notify the US Food and Drug Administration (FDA) of changes to an approved pharmaceutical application. The course also covers the levels of post-approval changes and the recommended chemistry, manufacturing, and control requirements for each level.

Featured Topics

Defining post-approval changes

Four categories of change

PAC guidance documents

Who Should Attend

Professionals and experts in the pharmaceutical, biotechnology, and medical device fields

Special Offers

Save by purchasing multiple UL EduNeering eLearning modules at one time. One to two modules cost $99 each, three to four cost $89 each, five to nine cost $80 each, and 10 or more cost $65 each.